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临床试验/NCT04575571
NCT04575571招募中不适用

The MAVIPAN Protocol: For a Structured Response to the Psychosocial Consequences of the Restrictive Measures Imposed by the Global Health COVID-19 Pandemic

Laval University1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2020年4月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
1
主要终点
Hostility subscale- Symptoms Checklist-90-Revised

研究概览

简要总结

The health crisis imposed by COVID-19 is forcing major worldwide social reorganization that will have profound consequences on our society. Currently, one-third of the world's population (~3 billion individuals) is living under some kind of isolation or quarantine measures, causing an unprecedented and rapidly evolving psychosocial crisis.

The psychosocial consequences of this health crisis will persist long after restriction measures are lifted and the pandemic is over. This impact will be significant for individuals facing unique contexts or challenges (e.g., older adults, individuals living with a disability, underprivileged families) and will most likely exacerbate existing social and gender inequalities in health and human development.

There is an urgent need for information on the evolution of the psychosocial dimensions of health and coping strategies used by our population and our health and social services structures. Thus, this study is designed to accelerate the availability of high-quality, real-time evidence within health and social services structures to address, support and minimize psychosocial consequences of the COVID-19 pandemic. Through constantly evolving research questions responsive to the course of the pandemic evolution, the rapid system transformations and adaptation of services, and knowledge users (KUs) needs, MAVIPAN aims to address, document, monitor, and evaluate the following:

  1. Individuals and families' adjustments and mitigation strategies, especially for those considered vulnerable and in high-risk contexts.
  2. Healthcare and social services workers and managers' adjustments and mitigation strategies.
  3. The organization of service structures.
  4. The social and economic response.

To achieve these objectives, we use a mixed methods study design that combines quantitative questionnaires and qualitative interviews to deepen our understanding of elements such as the coping strategies used during the pandemic. A first measure was taken during lock-down as well as a follow-up at 3 months. Another follow-up will be made at 7 months. At least one per year follow-up will be made over the course of the study (5 years). Additional measures may be taken depending on the evolution of the pandemic and the sanitary measures put in place by the authorities.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • General population

排除标准

  • Not a resident of the province of Quebec
  • Age under 14

结局指标

主要结局

Hostility subscale- Symptoms Checklist-90-Revised

时间窗: 7 months

Only the Hostility subscale that measures thoughts, feelings and actions characteristic of anger is used. Scores range from 6 to 24 and higher scores indicate higher level of hostility

Brief COPE

时间窗: Baseline (measured during lockdown in March 2020)

We use a subset of questions taken from the Brief Cope which measures coping strategies.

Child Conflict Tactic Scale

时间窗: Baseline (measured during lockdown in March 2020)

We use a subset of questions that measures the presence of minor physical abuse as well as psychological abuse.

Depression, Anxiety and Stress Scale-21 (DASS-21)

时间窗: 7 months

The DASS-21 is a measure of depression, anxiety and stress symptoms. The score on each subscale varies from 0 to 21. A higher score means a higher level of symptoms.

Insomnia Severity Index

时间窗: 7 months

Scores vary between 0 and 28. A higher score means greater insomnia severity.

Parental Stress Index

时间窗: Baseline (measured during lockdown in March 2020)

We only use the Interaction subscale which measures the extent to which the parent believes the child is not meeting expectations and finds interactions with the child are not reinforcing his parenting role.

Healthcare workers adaptation

时间窗: Baseline (measured during lockdown in March 2020)

We use a series of questions that assess different changes that may have occured in their work, as well as a series of beliefs they may hold concerning their work and their patients/clients.

Substance use

时间窗: 7 months

These are self-report questions that measure the change in consumption level of different substances such as alcool, prescriptions medications and illicit drugs prior and after the lockdown.

Warwick-Edinburgh Mental Well-Being Scale

时间窗: 7 months

Scores range from 7 to 35 and higher scores indicate higher positive well-being.

Dyadic Adjustment Scale

时间窗: Baseline (measured during lockdown in March 2020)

We use a subset of questions taken from the Dyadic Adjustment Scale which measures couple satisfaction.

Strengths and Difficulties Questionnaire

时间窗: Baseline (measured during lockdown in March 2020)

We use a subset of questions that aim to measure different child behaviors and personality caracteristics.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Annie Leblanc

Full Professor

Laval University

研究点 (1)

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